Early effects of oral administration of esomeprazole and omeprazole on the intragastric pH.

BACKGROUND/AIMS: The aim of our study was to investigate the inhibitory effects on gastric acid secretion of a single oral dose of a proton pump inhibitor, esomeprazole 20 mg and omeprazole 20 mg. METHODOLOGY: A total of 14 Helicobacter pylori-negative male subjects participated in this study. Intragastric pH was monitored continuously for 6 hours after a single oral dose of omeprazole 20 mg and a single oral dose of esomeprazole 20 mg. Each administration was separated by a 7-day washout period. RESULTS: During the 6-hour study period, the average pH after administration of esomeprazole was higher than that after the administration of omeprazole. Also during the 6-hour study period, each of pH > 2, 3, 3.5, 4, and 5 was maintained for a longer duration after administration of esomeprazole 20 mg than after administration of omeprazole 20 mg (median: 75.4% vs. 53.8%, p = 0.0138; 52.1% vs. 33.4%, p = 0.0188; 45.8% vs. 28.2%, p = 0.0262; 42.5% vs. 20.7%, p = 0.0414; 35.8% vs. 11.6%, p = 0.0262; respectively). CONCLUSIONS: In Helicobacter pylori-negative healthy male subjects, single oral administration of esomeprazole 20 mg increased the intragastric pH more rapidly than single oral administration of omeprazole 20 mg.

Prediction of non-biochemical recurrence rate after radical prostatectomy in a Japanese cohort: development of a postoperative nomogram.

OBJECTIVE: To develop a nomogram based on postoperative factors and prostate-specific antigen levels to predict the non-biochemical recurrence rate after radical prostatectomy ina Japanese cohort. METHODS: A total of 606 Japanese patients with T1-3N0M0 prostate cancer who underwent radical prostatectomy and pelvic lymph node dissection at Tokyo Medical University hospital from 2000 to 2010 were studied. A nomogram was constructed based on Cox hazard regression analysis evaluating the prognostic significance of serum prostate-specific antigen and pathological factors in the radical prostatectomy specimens. The discriminating ability of the nomogram was assessed by the concordance index (C-index), and the predicted and actual outcomes were compared with a bootstrapped calibration plot. RESULTS: With a mean follow up of 60.0 months, a total of 187 patients (30.9%) experienced biochemical recurrence, with a 5-year non-biochemical recurrence rate of 72.3%. Based on a Cox hazard regression model, a nomogram was constructed to predict non-biochemical recurrence using serum prostate-specific antigen level and pathological features in radical prostatectomy specimens. The concordance index was 0.77, and the calibration plots appeared to be accurate. CONCLUSIONS: The postoperative nomogram described here can provide valuable information regarding the need for adjuvant/salvage radiation or hormonal therapy in patients after radical prostatectomy.

Robotic versus open radical cystectomy: prospective comparison of perioperative and pathologic outcomes in Japan.

OBJECTIVE: In Japan, no study has compared the perioperative outcomes observed between robot-assisted radical cystectomy (RARC) and open radical cystectomy (ORC). This study aimed at a prospective comparison of the perioperative outcomes between RARC and ORC performed by a single surgeon. METHODS: Between 2008 and 2011, 26 bladder cancer patients underwent radical cystectomy by one surgeon, 11 robotically and 15 by open procedure. We prospectively collected perioperative and pathological data for these 26 patients, and retrospectively compared these two different surgical procedures. RESULTS: The RARC cohort had a significant decrease in both estimated blood loss (656.9 vs. 1788.7 ml, P=0.0015) and allogeneic transfusion requirement (0 vs. 40%, P=0.0237). The total operative time was almost the same (P=0.2306) but increased duration of bladder removal and lymphadenectomy was observed in the RARC cohort (P=0.0049). Surgery-related complication rates within 30 days were not significantly different (P=0.4185). Positive surgical margin was observed in three patients in the ORC cohort and in one patient in the RARC cohort (P=0.4664). The RARC cohort had a larger number of removed lymph nodes than the ORC cohort, and the difference was statistically significant (20.7 vs. 13.8, P=0.0421). CONCLUSIONS: We confirmed that RARC is safe and yields acceptable outcomes in comparison with ORC for the treatment of bladder cancer if it is performed by a surgeon who has experience of over 60 cases of robot-assisted radical prostatectomy. It is hoped that RARC will gain acceptance in Japan as a minimally invasive surgery for muscle-invasive bladder cancer.

Single-agent gemcitabine in elderly patients with unresectable biliary tract cancer.

BACKGROUND/AIMS: This study examines the effect of systemic chemotherapy with gemcitabine (GEM) on survival in elderly patients (aged > or =70 years) with unresectable biliary tract cancer and compares it with best supportive care (BSC). METHODOLOGY: We conducted a retrospective study of consecutive patients aged > or =70 years, with unresectable biliary tract cancer who were administered GEM (800-1000 mg/m2) on days 1, 8, and 15 every 4 weeks as a first-line treatment. RESULTS: Twenty-eight patients were enrolled: 13 (46.4%) received chemotherapy with GEM and 15 (53.6%) received BSC. No cases of complete or partial response were observed. Stable disease was observed in 9 patients (69.2%) and progressive disease in 2 patients (15.4%). Disease control rate was 69.2%. The median overall survival time of patients treated with GEM and BSC was 9.1 and 2.9 months, and the 1-year survival rates were 15.4% and 6.7% respectively. Grade 3/4 neutropenia occurred in three patients (23.1%), leukopenia in two patients (15.4%) and anemia in one patient (7.7%). Grade 3 non-hematologic toxicities were constipation (7.7%) and fatigue (7.7%). CONCLUSIONS: Chemotherapy with single-agent GEM is a safe and well tolerated regimen for elderly patients with unresectable biliary tract cancer.

Clinical efficiency of combination therapy using testosterone replacement therapy, phosphodiesterase 5 inhibitors and Kampo herbal medicine for eugonadal patients with late-onset hypogonadism syndrome.

In the present study, the initial treatment efficiency of combination therapy using testosterone replacement therapy (TRT), herbal medicine and phosphodiesterase 5 inhibitors (PDE5i) in male patients with late-onset hypogonadism (LOH) were assessed. A total of 21 patients were enrolled and after 12 weeks, the clinical efficacy was evaluated based on improvement of LOH symptoms via laboratory parameters and several questionnaires, including the Ageing Males' Symptoms (AMS) scale. The overall AMS scores, as well as the psychological, physical and sexual AMS factors prior to and after treatment in the TRT, testosterone enanthate (T enanthate) monotherapy and T enanthate + PDE5i treatment groups were significantly improved. In the herbal medicine group, only the AMS physiological factors were significantly improved after treatment compared with the baseline. The improvement of the overall AMS scores, as well as the physiological and sexual AMS factors, were significantly negatively correlated with the free testosterone (FT) value prior to treatment. In conclusion, treatment with combination therapy using TRT, herbal medicine and PDE5i improved AMS scores in patients with LOH syndrome. Particularly in patients with LOH syndrome and low FT, the symptoms were significantly improved following combination therapy.

Association between preoperative serum total cholesterol level and biochemical recurrence in prostate cancer patients who underwent radical prostatectomy.

The aim of this study was to investigate the association between serum total cholesterol (TC) level and biochemical recurrence (BCR) following radical prostatectomy (RP). The study included 562 patients with T1-3N0M0 prostate cancer, who underwent RP at our institution between 2002 and 2010. No patients received neoadjuvant and/or adjuvant therapy. The associations between preoperative TC level, clinicopathological factors and BCR were assessed using univariate and multivariate analyses. During follow-up (mean, 54.0 months), 168 patients (168/562, 29.9%) experienced BCR, with a 5-year BCR-free rate of 67.2%. Of the clinicopathological characteristics investigated, statin use and lymphovascular invasion (LVI) status were associated with lower TC level (P=0.003 and P=0.014, respectively). In the univariate analysis, a higher serum prostate-specific antigen (PSA) level at diagnosis, extracapsular extension, positive surgical margin, seminal vesicle invasion, LVI, perineural invasion, higher Gleason score (GS ≥8) based on the RP specimen, increased body mass index, and low preoperative TC level, were significantly associated with BCR. In the multivariate analysis, the TC level was an independent predictor of BCR (hazard ratio = 0.925 per 10 mg/dl; 95% confidence interval: 0.879-0.973; P=0.003), as was the serum PSA level, extracapsular extension, positive surgical margin and the GS. Low preoperative serum TC levels were associated with an increased risk of BCR among prostate cancer patients who underwent RP. Our findings suggest that the preoperative serum TC level may provide important clinical information that may prove to be useful in patient counseling.

Associations between ABO blood groups and biochemical recurrence after radical prostatectomy.

BACKGROUND: Recent studies have demonstrated associations between ABO blood groups and prognosis in various types of cancers. The aim of this study was to investigate the association between ABO blood groups and biochemical recurrence (BCR) after radical prostatectomy (RP). METHODS: A total of 555 patients with prostate cancer who underwent RP were included in the study. No patients received neoadjuvant and/or adjuvant therapy. The effect of ABO blood groups on BCR was examined using univariate and multivariate analyses. RESULTS: During the follow-up period (mean, 52.0 months), 166 patients (29.9%) experienced BCR, with a 5-year BCR-free rate of 67.3%. Although the ABO blood group was not a significantly associated with BCR in the univariate analysis, it was an independent predictor of BCR in the multivariate analysis: blood type O patients had a significantly lower risk of BCR compared to type A patients (Hazard ratio, 0.608; 95% confidence interval, 0.410-0.902; P = 0.014). Further analyses revealed that surgical margin status confounded the assessment of the association between the ABO blood group and BCR. In the analyses of patients with a negative surgical margin, the 5-year BCR-free rate in blood type O patients was a significantly higher than that in type A patients (91.2% vs. 71.0%; P = 0.026). CONCLUSION: Blood type O is significantly associated with a decreased risk of biochemical recurrence after radical prostatectomy. Further studies are needed to clarify the nature of this association.